Overview

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Advisory Board

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Student Profile

James Martucci

Jim Martucci is a Lead Innovator coordinating technology assessment and scouting for Baxter Healthcare. He has over 30 years of experience in medical device product development, including electronics design for implantable pacemakers at Cordis Corporation and program management and technical leadership positions at Baxter for the development of pharmacy compounding systems, infusion pumps, device interoperability and usability / simulated use studies. Martucci also managed three Phase II clinical studies of clinical nutrition compounds in “pharma applications” (ARDS, AIDS and cardiovascular). “New to world” products included the first dual chamber pacing/sensing pacemaker, pharmacy micro compounder and compounder with in-line fluid type sensing. Martucci presented to FDA for Cordis on implantable pacemakers and for Baxter on “Industry Guidance for Pharmacy Compounders and Software”, which was formally adopted by the agency; he led five successful 510(k) submissions from 1993 to 2005. He is a registered Professional Engineer (IL), Project Management Professional (PMP), CMii certified, Green Belt and DMAIC trained; an inventor on approximately 23 issued patents and a co-authored a publication in Circulation (Short Term Cholesterol Lowering Decreases Size and Severity of Perfusion Abnormalities by PET in Patients With Coronary Artery Disease, April, 1994).

Patents

Regulatory Experience

Led five successful 510(k) submissions from 1993 to 2005Contributed to two successful IND submissions in 1993-1994Presentation to FDA led to Industry Guidance for Pharmacy Compounders and Software, July, 200

Education

BS Electrical Engineering, University of MichiganMS Biomedical Engineering, University of MiamiMaster of Engineering Management, Northwestern University